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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Sponsor: A.M.I. Agency for Medical Innovations GmbH
Summary
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation. The primary objective is to verify the treatment outcome and success of the ProGYNious mesh implant in pelvic organ prolapse repair. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-04-15
Completion Date
2028-09-30
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Surgical mesh for pelvic organ prolapse repair (ProGYNious)
Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy
Locations (5)
Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe
Wiener Neustadt, Lower Austria, Austria
Kardinal Schwarzenberg Klinikum
Schwarzach im Pongau, Salzburg, Austria
Universitätsklinikum Erlangen, Frauenklinik
Erlangen, Bavaria, Germany
Klinik Agatharied, Gynäkologie & Geburtshilfe
Hausham, Bavaria, Germany
Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, Hesse, Germany